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LORBRENA®Indications and Usage (lorlatinib)

1 INDICATIONS AND USAGE

LORBRENA® is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on

  • crizotinib and at least one other ALK inhibitor for metastatic disease; or
  • alectinib as the first ALK inhibitor therapy for metastatic disease; or
  • ceritinib as the first ALK inhibitor therapy for metastatic disease.

This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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